Devices for minimally invasive procedures

ABSTRACT

The invention relates to an assembly for use in minimally invasive surgical procedures, including bone implant fixation procedures. The assembly is configured to provide a faster and more accurate measurement of depth of holes for placement of bone screws and fasteners. The assembly includes a guidewire having a deployable distal hook member configured to securely anchor into a desired position relative to a hole drilled in a bone and thereby provide an accurate datum for a measuring instrument for determining a depth of the hole for subsequent screw placement. The assembly further includes a surgical depth instrument to cooperatively function with the guidewire and obtain one or more measurements while operably coupled to the guidewire.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of, and priority to, U.S.Provisional Application No. 62/519,845, filed Jun. 14, 2017, the contentof which is hereby incorporated by reference herein in its entirety.

FIELD

The present disclosure relates generally to medical devices, and, moreparticularly, to a measuring system for use in a minimally invasivesurgical procedure, such as a bone implant fixation procedure, themeasuring system includes a guidewire member having a deployable hookmember configured to securely anchor into a desired position relative toa hole drilled in a bone and thereby provide an accurate datum for ameasuring instrument for determining a depth of the hole for subsequentscrew placement.

BACKGROUND

Orthopedics is a medical specialty concerned with the correction ofdeformities or functional impairments of the skeletal system, especiallythe extremities and the spine, and associated structures, such asmuscles and ligaments. Some orthopedic surgical procedures requiresurgeons to secure a device to one or more bones of a patient. Forexample, in some procedures, the surgeon may span and secures one ormore bones, or pieces of a single bone, using a bone plate and one ormore fasteners, such as screws. Other bone-related surgical procedures,however, may not require a bone plate and may instead solely rely on theuse of one or more screws (e.g., securing a transplanted tendon).

In such bone-related surgical procedures, before an implant or plate, orsimply the screw itself, can be attached to bone, an opening istypically drilled into the bone to accommodate the screw. With a hole inplace, the surgeon can more easily select a screw of the appropriatelength. However, selecting a screw of appropriate length is critical.For example, if the selected screw is too long, the distal end of thescrew may pass through the end of the drilled hole and cause damage tothe bone and/or protrude entirely through the bone, which can havedeleterious effects, such as damage to surrounding tissue and/or painand discomfort, or more serious complications, for the patient. Forexample, in some instances, the bone may abut against soft tissues thatmay be harmed if the screw is too long and may result in irritation ofor damage to the soft parts. Additionally, a screw that protrudesthrough the bone may be tactilely felt by the patient, may prevent softtissues (e.g., tendons, ligaments, or muscles) from moving over the bonesurface as intended, or may even pierce the skin, which can lead toserious infection and complications.

The selection of an appropriate length screw is particularly importantin spinal fixation procedures, such as lumbar sacral fusion and thecorrection of spinal deformities such as scoliotic curves. As anexample, a screw mounted in the pedicle portion of the human spineshould not extend to a point where the screw contacts the spinal corditself, an event that can cause irreparable nervous system damageincluding paralysis. Accordingly, the determination of a length of thehole is important for choosing the appropriate length screw.

During drilling, the surgeon is typically capable of recognizing theresistance on the drill in order to determine when the drill haspenetrated through the bone. Because the simple act of drilling does notprovide an exact measurement of the depth of the bone itself, a depthgauge is commonly employed for directly measuring the depth of the holefrom the top, drilling side to the bottom, opposite side of the hole.

Currently, many designs are known and utilized for measuring the depthof a hole or bore in a portion of a bone. Generally speaking, thesedesigns utilize a central probe member having a barb at a distal end,and a sleeve or channel member. The probe member is inserted into thepilot hole while the surgeon attempts to find the surface with the barb.More specifically, the probe member is inserted to a depth greater thanthe depth of the pilot hole so that the barb is beyond the oppositeside, at which point the surgeon finds the surface by hooking the barbto the opposite side.

The probe member is received in the sleeve or channel member and mayreciprocate relative thereto. The channel member has graduated markingsalong a portion of its length, typically in inches and/or millimeters. Amarker is laterally secured to the probe member such that, as the probemember shifts relative to the channel member, the marker indicates therelative shift between the probe member and the channel member.Accordingly, once the probe member has been secured to the opposite sideof the bone, the channel member is shifted relative to the probe memberand toward the bone until the channel member abuts the surface of thebone. The depth gauge is then read by examining graduated markingsindicated by the probe member marker.

A number of problems are experienced with this depth gauge. As aninitial point, the components are typically made with surgical-gradestainless steel, and the graduated markings are embossed therein.Therefore, the brightness of the operating room lights on the highlyreflective surface can make the markings difficult to read. The markingsare commonly in small increments, such as millimeters, and surgeonsoften have trouble differentiating between the markings, or notingpartial increments. Reading these gauges, then, often requires carefullyholding the depth gauge as the reading is taken, and a surgeon's effortto closely examine the reading may result in a loss of securement orpurchase of the barb on the bone, thus necessitating a re-measurementand a loss of time.

Furthermore, proper reading of the markings requires a surgeon's eyes tobe properly aligned with the markings. That is, a proper view of themeasurement requires the surgeon to view the gauge from a lateral pointof view so that the view of the probe marker aligned with the graduatedmarkings is proper not distorted by the surgeon's elevated, standingperspective. Therefore, it is often necessary for the surgeon to bendover while using these gauges to view an accurate reading. If the depthgauge is tilted in order to make the reading, the sleeve will shiftrelative to the probe, thus making the measurement inaccurate andpossibly causing the barb to become unsecured, as described above. Inaddition, removal of the depth gauge often causes the measurement to belost. As the bone is essentially clamped, by light pressure, between thedistal end of the channel member and the distal barb of the probemember, it is often necessary to retract the channel member from thebone surface in order to extract the probe from the pilot hole.

SUMMARY

The present disclosure is a medical system for use in a minimallyinvasive surgical procedure, such as a bone implant fixation procedure,and is configured to provide a faster and more accurate measurement ofdepth of holes for placement of bone screws and fasteners. The systemmay be used in any bone implant fixation procedure, including, forexample, percutaneous pedicle screw fixation, which may include, but isnot limited to, anterior lumbar interbody fusion, lateral interbodyfusion, and posterior lumber interbody fusion or transforaminal lumbarinterbody fusion.

The medical system includes a guidewire having a deployable distal hookmember configured to securely anchor into a desired position relative toa hole drilled in a bone. The distal hook member is configured totransition between a delivery configuration, in which the distal hookmember can be positioned within and move through a drilled hole to adesired position, and a deployed configuration, in which the distal hookmember is configured to anchor into place, either within the hole (e.g.,along a length of a hole, either mono-cortical or bi-cortical, or at thebase of a mono-cortical hole) or outside of the hole (e.g., on opposingside of a bi-cortical drilled hole). In particular, the hook memberincludes a plurality of struts or splines, each of which includes adistal end fixedly coupled to a distal-most end of the guidewire and aproximal end fixedly coupled to a portion of the guidewire bodypositioned a distance from the distal-most end of the guidewire.Accordingly, the plurality of struts share common fixation points attheir respective distal and proximal ends to form a basket-like ormushroom-like structure.

The guidewire further includes a pull-wire or other mechanism coupled tothe distal-most end of the guidewire and configured to assist the hookmember from transitioning between the delivery and deployedconfigurations. More specifically, the plurality of struts may be madeof a resilient, biologically inert material, such as NITINOL metal,stainless steel, or silicone rubber, for example, and may be arrangedeither symmetrically or asymmetrically about a longitudinal axis of thehook member. When in the default state (i.e., no application of pullingforce upon the pull-wire), the hook member may remain in a deliveryconfiguration, in which the hook member has a relatively compact sizeand may be freely positioned within a drilled hole or other passage. Dueto the resilient nature of the material from which the struts are madefrom, the hook member may be pushed into a drilled hole until reaching adesired position (i.e., either the bottom of the hole or entirelythrough the hole if a bicortical drill hole). Upon reaching the desiredposition, a user (i.e., surgeon or other medical professional) need onlyapply a pulling force upon the pull-wire, which, in turn, results inretraction of the distal-most end of the guidewire, thereby causing thedistal end of each of the plurality of struts coupled thereto to movetowards the opposing proximal end of each strut and causing the hookmember to expand in diameter and thereby transition to the deployedconfiguration.

The expansion in diameter of the hook member results in anchoring of thehook member in a desired position. For example, if the hook member istransitioned to the deployed configuration within the drilled hole, theexpanded diameter causes the struts to engage interior walls of thedrilled hole, thereby lodging the hook member within. In some proceduresin which a plate or implant is to be secured with screws through abicortical drill hole, the distal hook member may be advanced entirelythrough the hole (from one side of the bone to the other), at whichpoint the surgeon may then transition the hook member to the deployedconfiguration, in which the expanded diameter is much greater than thedrilled hole diameter and opening, and thus the user need only pull backon the guidewire until the expanded hook member securely engages theexterior surface of the bone adjacent to the drilled hole.

The guidewire is configured to assist in depth measurement procedures,as well as the placement of the screw(s) and/or implant(s). For example,the guidewire may be compatible with a variety of separate medicalinstruments, which may include measuring devices for determining thedepth of the hole, as well as other medical instruments used in a boneimplant fixation procedure, such as tools for the placement of thescrew(s) and/or implant(s). For example, an exemplary measuringinstrument may include a sleeve member having a bore extendingtherethrough and configured to receive the guidewire body. Accordingly,the sleeve member may be slid onto the guidewire, by way of the bore,and may translate along a length of the guidewire, either duringpositioning and anchoring of the distal hook member or once the distalhook member is deployed and anchored in position. The measuringinstrument may further include a needle or probe configured to beslidably mounted within sleeve member, by way of the bore, while thesleeve member is coupled to the guidewire. For example, the bore of thesleeve member may be shaped and/or sized to accommodate both theguidewire body and the needle or probe. Yet still, in other embodiments,the needle or probe may be hollow, such that the needle or probe mayreceive the guidewire within, thereby allowing for the needle or probeto translate along a length of the guidewire.

Accordingly, once the hook member is anchored in place, the guidewireprovides improved stability during a depth measurement procedure and/orscrew placement procedure, as the guidewire essentially acts as a guidefor the sleeve member and/or needle or probe to slide along a lengththereof. Furthermore, the hook member provides an accurate datum fromwhich the depth of the hole can be determined, thereby improving theprecision with which depths of holes can be determined. For example,upon establishing an anchored position with the hook member, a user needonly slide the sleeve member towards the drilled hole until adistal-most end of the slide member, which is tapered, engages theopening of the hole and establishes engagement and maintains the sleevemember in a stabilized position, at which point, the needle or probe canbe used for measuring the depth of the hole.

The measuring instrument further includes at least one sensor configuredto generate an electronic signal indicative of a depth of the hole as aresult of sensing a distance of movement of the needle or probe into thedrilled hole. For example, in one embodiment, a surgeon need onlyadvance the needle or probe into the hole until they establishengagement between the distal tip of the needle or probe with theanchored hook member. Again, the guidewire essentially acts as a guideupon which the needle or probe may either slide over, or slidealongside, when advancing to the anchored hook member, which providesthe datum from which the depth of the hole is determined.

The sensor is configured to generate an electronic signal based on adistance of movement of needle or probe member, wherein the electronicsignal is indicative of at least a depth of the hole. In particular, thesensor may include inductive or capacitive elements or assembliesconfigured to sense the location of the distal tip of the needle orprobe relative to a distal end of the sleeve member, and, as a result,generate an electronic signal representing the distance there between.Accordingly, the sensed distance between the distal end of the sleevemember (when abutting the bone surface) and the distal tip of the needleor probe member (when abutting the anchored hook member) is the depth ofthe hole. In some embodiments, the sensor system may include apotentiometer arrangement. In some embodiments, the sensor system fordetermining depth may include a worm gear measurement system, whereinthe sleeve member may include a pinion gear and the needle or probe mayhave a corresponding worm gear configuration. Yet still, in someembodiments, the sensor system may include a laser diode configured toread or otherwise sense machine-readable markings on the needle or probeto determine distance traveled when determining/calculating depth of thedrilled hole.

It should be noted that the device may include logic or allow foradjustment to the sensing capabilities so as to program the sensor toaccount for other variables when sensing the depth of the hole. Forexample, in some embodiments, certain procedures require fixing a plateor implant to the bone via screws. Accordingly, the screw length mustnot only be sufficient to fill the hole but also long enough to accountfor the thickness of a plate or implant through which it passes whenengaging the hole. Accordingly, in some embodiments, the sensor may beprogrammed so as to account for the thickness of the plate or implantand will further include that thickness in the electronic signalproduced, such that the electronic signal is indicative of the totaldepth that a corresponding screw length will need to cover, includingthe depth of the hole in the bone in addition to the thickness of theplate or implant through which the screw will pass through and the screwhead will engage.

Accordingly, the digital sensing of the hole depth provides a much moreaccurate measurement than conventional analog depth gauges and alsorequiring very little, if any, input or interpretation from the surgeon.Accordingly, by providing a much more accurate measurement of a holedepth, the surgeon is able to select the correct length screw for anygiven hole so as to improve the chances of a successful surgery.

In some embodiments, the measuring instrument may further include adisplay provided on the body and configured to visually provide adigital readout of a depth measurement of the hole based on theelectronic signal from the sensor. In other embodiments, the measuringinstrument may be configured to wirelessly communicate and exchange datawith a separate display or computing device, such as, for example, amonitor or panel display, a PC, a notebook, a tablet computer, asmartphone, or other wireless computing device.

Upon receiving the electronic signal from the sensor, the separatedisplay or computing device may be configured to visually provide thedepth measurement of the hole based on the electronic signal from thesensor. Furthermore, in some embodiments, the computing device mayinclude a specific software application that may be directed tomaintaining a record of the hole measurements and/or provide aninteractive user interface in which multiple holes can be mapped to aparticular plate or implant and the depth of each hole (including thethickness of the plate or implant) can be included and stored forrecords.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the claimed subject matter will be apparentfrom the following detailed description of embodiments consistenttherewith, which description should be considered with reference to theaccompanying drawings, wherein:

FIG. 1 is perspective view of one embodiment of a guidewire assembly ofthe minimally invasive surgical depth instrument consistent with thepresent disclosure, illustrating the distal hook member in the deliveryconfiguration;

FIG. 2 is a side view of the guidewire assembly of FIG. 1;

FIG. 3 is a side cross-sectional view of the guidewire assembly takenalong lines A-A of FIG. 2;

FIG. 4 is perspective view of the guidewire assembly illustrating thedistal hook member in the deployed configuration;

FIG. 5 is a side view of the guidewire assembly of FIG. 4;

FIG. 6 is a side cross-sectional view of the guidewire assembly takenalong lines B-B of FIG. 5;

FIGS. 7A and 7B are perspective views of the guidewire assemblyillustrating the transition of the distal hook member from the deliveryconfiguration (FIG. 7A) to the deployed configuration (FIG. 7B);

FIG. 8 is a perspective view of a sleeve member of the surgical depthinstrument consistent with the present disclosure, illustrating thesleeve member slidably mounted to the guidewire assembly;

FIG. 9 is a perspective view of the needle or probe member of thesurgical depth instrument relative to the corresponding sleeve member;

FIGS. 10A and 10B are side views of an assembled surgical depthinstrument consistent with the present disclosure illustrating movementof the needle or probe from a starting position (FIG. 10A) to anextended position (FIG. 10B) for measurement of a hole depth;

FIGS. 11A and 11B are side cross-sectional views of the assembledsurgical depth instrument taken along lines C-C of FIGS. 10A and 10B,respectively;

FIGS. 12 and 13 are cross-sectional views of the sleeve memberillustrating different sensor systems/arrangements for determining depthof a drilled hole; and

FIGS. 14A-14H illustrate a series of steps for performing a procedure ofdeploying the hook member of the guidewire and subsequently obtaining adepth measurement using the surgical depth instrument consistent withthe present disclosure.

For a thorough understanding of the present disclosure, reference shouldbe made to the following detailed description, including the appendedclaims, in connection with the above-described drawings. Although thepresent disclosure is described in connection with exemplaryembodiments, the disclosure is not intended to be limited to thespecific forms set forth herein. It is understood that various omissionsand substitutions of equivalents are contemplated as circumstances maysuggest or render expedient.

DETAILED DESCRIPTION

By way of overview, the present disclosure is generally directed to amedical system for use in a minimally invasive surgical procedure, suchas a bone implant fixation procedure, and is configured to provide afaster and more accurate measurement of depth of holes for placement ofbone screws and fasteners. The system may be used in any bone implantfixation procedure, including, for example, percutaneous pedicle screwfixation, which may include, but is not limited to, anterior lumbarinterbody fusion, lateral interbody fusion, and posterior lumberinterbody fusion or transforaminal lumbar interbody fusion.

The medical system includes a guidewire having a deployable distal hookmember configured to securely anchor into a desired position relative toa hole drilled in a bone. The distal hook member is configured totransition between a delivery configuration, in which the distal hookmember can be positioned within and move through a drilled hole to adesired position, and a deployed configuration, in which the distal hookmember is configured to anchor into place, either within the hole (e.g.,at the base of a mono-cortical hole) or outside of the hole (e.g., onopposing side of a bi-cortical drilled hole). In particular, the hookmember includes a plurality of struts or splines, each of which includesa distal end fixedly coupled to a distal-most end of the guidewire and aproximal end fixedly coupled to a portion of the guidewire bodypositioned a distance from the distal-most end of the guidewire.Accordingly, the plurality of struts share common fixation points attheir respective distal and proximal ends to form a basket-like ormushroom-like structure.

The guidewire further includes a pull-wire or other mechanism coupled tothe distal-most end of the guidewire and configured to assist the hookmember from transitioning between the delivery and deployedconfigurations. More specifically, the plurality of struts may be madeof a resilient, biologically inert material, such as NITINOL metal,stainless steel, or silicone rubber, for example, and may be arrangedeither symmetrically or asymmetrically about a longitudinal axis of thehook member. When in the default state (i.e., no application of pullingforce upon the pull-wire), the hook member may remain in a deliveryconfiguration, in which the hook member has a relatively compact sizeand may be freely positioned within a drilled hole or other passage. Dueto the resilient nature of the material from which the struts are madefrom, the hook member may be pushed into a drilled hole until reaching adesired position (i.e., either the bottom of the hole or entirelythrough the hole if a bicortical drill hole). Upon reaching the desiredposition, a user (i.e., surgeon or other medical professional) need onlyapply a pulling force upon the pull-wire, which, in turn, results inretraction of the distal-most end of the guidewire, thereby causing thedistal end of each of the plurality of struts coupled thereto to movetowards the opposing proximal end of each strut and causing the hookmember to expand in diameter and thereby transition to the deployedconfiguration.

The expansion in diameter of the hook member results in anchoring of thehook member in a desired position relative to the drilled hole. Forexample, if the hook member is transitioned to the deployedconfiguration within the drilled hole, the expanded diameter causes thestruts to engage interior walls of the drilled hole, thereby lodging thehook member within the hole at a desired position within the hole. Thismay be advantageous when cannulated screws are to be used, such that acannulated screw can essentially ride along the guidewire when placedwithin the hole. In some procedures in which a plate or implant is to besecured with screws through a bicortical drill hole, the distal hookmember may be advanced entirely through the hole (from one side of thebone to the other), at which point the surgeon may then transition thehook member to the deployed configuration, in which the expandeddiameter is much greater than the drilled hole diameter and opening, andthus the user need only pull back on the guidewire until the expandedhook member securely engages the exterior surface of the bone adjacentto the drilled hole.

The guidewire is configured to assist in depth measurement procedures,and may further be configured to assist in the placement of the screw(s)and/or implant(s). For example, the guidewire may be compatible with avariety of separate medical instruments, which may include measuringdevices for determining the depth of the hole, as well as other medicalinstruments used in a bone implant fixation procedure, such as tools forthe placement of the screw(s) and/or implant(s). For example, anexemplary surgical depth instrument may include a sleeve member having abore extending therethrough and configured to receive the guidewirebody.

Accordingly, the sleeve member may be slid onto the guidewire, by way ofthe bore, and may translate along a length of the guidewire, eitherduring positioning and anchoring of the distal hook member or once thedistal hook member is deployed and anchored in position. The measuringinstrument may further include a needle or probe configured to beslidably mounted within sleeve member, by way of the bore, while thesleeve member is coupled to the guidewire. For example, the bore of thesleeve member may be shaped and/or sized to accommodate both theguidewire body and the needle or probe. Yet still, in other embodiments,the needle or probe may be hollow, such that the needle or probe mayreceive the guidewire within, thereby allowing for the needle or probeto translate along a length of the guidewire.

Accordingly, once the hook member is anchored in place, the guidewireprovides improved stability during a depth measurement procedure and/orscrew placement procedure, as the guidewire essentially acts as a guidefor the sleeve member and/or needle or probe to slide along a lengththereof. Furthermore, the hook member provides an accurate datum fromwhich the depth of the hole can be determined, thereby improving theprecision with which depths of holes can be determined. For example,upon establishing an anchored position with the hook member, a user needonly slide the sleeve member towards the drilled hole until adistal-most end of the slide member, which is tapered, engages theopening of the hole and establishes engagement and maintains the sleevemember in a stabilized position, at which point, the needle or probe canbe used for measuring the depth of the hole.

FIG. 1 is perspective view of one embodiment of a guidewire assembly 100consistent with the present disclosure. FIG. 2 is a side view of theguidewire assembly 100 and FIG. 3 is a side cross-sectional view of theguidewire assembly 100 taken along lines A-A of FIG. 2. The guidewireassembly 100 generally includes a deployable hook member 102 at a distalend of the guidewire 100. The distal hook member 102 includes aplurality of struts or splines 104(1)-104(6), each of which includes adistal end fixedly coupled to a distal-most end 106 of the guidewire 100and a proximal end fixedly coupled to a portion of the guidewire body108 positioned a distance from the distal-most end 106. Accordingly, theplurality of struts 106 share common fixation points at their respectivedistal and proximal ends to form a basket-like or mushroom-likestructure.

The plurality of struts 104 may be made of a resilient, biologicallyinert material, such as NITINOL metal, stainless steel, or siliconerubber, for example, and may be arranged either symmetrically orasymmetrically about a longitudinal axis of the hook member 102.Although shown with a total of six struts 104(1), 104(2), 104(3),104(4), 104(5), and 104(6), it should be noted that a hook member 102consistent with the present disclosure may include more or less than sixstruts and is thus not limited to any number of struts.

The hook member 102 is configured to transition between a deliveryconfiguration, as illustrated in FIGS. 1-3, and a deployedconfiguration, as shown in FIGS. 4-6. In particular, guidewire assembly100 may further include a guide tube or cover 110 configured to providerigidity to the guidewire 100 during positioning in a drilled hole, apull rod 112, and a pull-wire 114 coupled to the pull rod 112 andcoupled to the distal-most end 106 of the guidewire 100. The pull rod112 and pull-wire 114 are configured to assist the hook member 102 fromtransitioning between the delivery and deployed configurations. Forexample, when in the default state (i.e., no application of pullingforce upon the pull-rod 112 and pull-wire 114), the hook member 102 mayremain in a delivery configuration, in which the hook member 102 has arelatively compact size and has a first diameter D₁. When in thedelivery configuration and due to its compact size, the hook member 102may be freely positioned within and move through a drilled hole or otherpassage to a desired position. Due to the resilient nature of thematerial from which the struts are made from, the hook member 102 may bepushed into a drilled hole until reaching a desired position (i.e.,either the bottom of the hole or entirely through the hole if abicortical drill hole).

Upon reaching the desired position, a user (i.e., surgeon or othermedical professional) need only apply a pulling force upon the pull-wire114 (i.e., pull the pull rod 112), which, in turn, results in retractionof the distal-most end 106 of the guidewire 100, thereby causing thedistal end of each of the plurality of struts 104 coupled thereto tomove towards the opposing proximal end of each strut and cause the hookmember 102 to expand in diameter and thereby transition to the deployedconfiguration, as shown in FIGS. 4-6. For example, when in the deployedconfiguration, the hook member 102 has a second diameter D₂ which isgreater than the first diameter D₁ when the hook member 102 is in thedelivery configuration.

FIGS. 7A and 7B are perspective views of the guidewire 100 illustratingthe transition of the hook member 102 from the delivery configuration(FIG. 7A) to the deployed configuration (FIG. 7B). The expansion indiameter of the hook member 102 results in anchoring of the hook member102 in a desired position. When in the deployed configuration, the hookmember 102 is configured to anchor into place, either within the hole(e.g., at the base of a mono-cortical hole) or outside of the hole(e.g., on opposing side of a bi-cortical drilled hole). For example, ifthe hook member 102 is transitioned to the deployed configuration withinthe drilled hole, the expanded diameter causes the struts 104 to engageinterior walls of the drilled hole, thereby lodging the hook member 102within. In some procedures in which a plate or implant is to be securedwith screws through a bicortical drill hole, the distal hook member maybe advanced entirely through the hole (from one side of the bone to theother), at which point the surgeon may then transition the hook memberto the deployed configuration, in which the expanded diameter is muchgreater than the drilled hole diameter and opening, and thus the userneed only pull back on the guidewire 100 until the expanded hook member102 securely engages the exterior surface of the bone adjacent to thedrilled hole. Due to the resilient nature of the material of the struts,the hook member may essentially flatten against the surface of the boneupon a user pulling back on the guidewire, wherein such flattening mayenhance tactile feel, providing the user with an indication that thehook member is sufficiently anchored. The user can maintain the tensionon the pull-wire 114 by simply winding a portion of the pull-wire 114around the pull rod 112 and subsequently reestablishing a connectionbetween the pull rod 112 and the need only position the pull rod 112 inthe guide tube or cover 114, as shown in FIGS. 5 and 6. When the userwishes to disengage the hook member 102 from an anchored position, theyneed only release the tension on the pull-wire 114 and the struts 104will return to their default shape, thereby returning the hook member102 to the delivery configuration, at which point the guidewire 100 canbe removed.

The guidewire 100 is configured to assist in depth measurementprocedures, as well as the placement of the screw(s) and/or implant(s).For example, the guidewire may be compatible with a variety of separatemedical instruments, which may include measuring devices for determiningthe depth of the hole, as well as other medical instruments used in abone implant fixation procedure, such as tools for the placement of thescrew(s) and/or implant(s).

For example, an exemplary measuring or surgical depth instrument mayinclude a sleeve member 200 and a needle or probe member 300 compatiblefor use with the guidewire 100. FIG. 8 is a perspective view of thesleeve member 200 slidably mounted to the guidewire 100 and FIG. 9 is aperspective view of the needle or probe member 300 of the surgical depthinstrument relative to the corresponding sleeve member 200.

As shown, the sleeve member 200 generally includes an elongate body 202,which may serve as a handle for the user during a procedure, wherein thebody 202 has a distal end 204 and a proximal end 206, as well as a bore208 extending entirely through the body 202 from the distal end 204 tothe proximal end 206. The bore 208 is shaped and/or sized to receive theguidewire body therein. Accordingly, the sleeve member 200 may be slidonto the guidewire 100, by way of the bore 208, and may therebytranslate along a length of the guidewire 100, either during positioningand anchoring of the distal hook member 102 or once the distal hookmember 102 is deployed and anchored in position. As will be described ingreater detail herein, the distal end 204 of the sleeve member 200 isconfigured to engage at least an opening of a drilled hole during aprocedure and a flanged member 205 generally serves as a abuttingfeature for engaging the exterior surface of the bone along a peripheryof the hole opening.

The surgical depth instrument may further include a needle or probe 300.The needle or probe 300 includes a handle 302, an elongate body 304extending from the handle 302, and a distal tip 306. For sake of clarityand ease of description, the needle or probe 300 is hereinafter referredto as “probe 300”. The probe 300 is configured to be slidably mountedwithin the sleeve member 200, by way of the bore 208, while the sleevemember 200 is coupled to the guidewire 100. For example, the bore 208 ofthe sleeve member 200 may be shaped and/or sized to accommodate both theguidewire 100 and the probe 300. Yet still, in other embodiments, theprobe 300 may be hollow, such that the probe 300 may receive theguidewire 100 within, thereby allowing for the probe 300 to translatealong a length of the guidewire 100 and further slide along a length ofthe sleeve member 200.

Accordingly, once the hook member 102 is anchored in place, theguidewire 100 provides improved stability during a depth measurementprocedure and/or screw placement procedure, as the guidewire 100essentially acts as a guide for the sleeve member 200 and/or probe 300to slide along a length thereof. Furthermore, the hook member 100provides an accurate datum from which the depth of the hole can bedetermined, thereby improving the precision with which depths of holescan be determined.

For example, upon establishing an anchored position with the hook member102, a user need only slide the sleeve member 200 towards the drilledhole until a distal-most end 204 of the slide member 200, which istapered, engages the opening of the hole and establishes engagement andmaintains the sleeve member 200 in a stabilized position, at whichpoint, the probe 300 can be used for measuring the depth of the hole. Insome embodiments, the distal end 204 may further include edges or prongsthat, upon rotation of the sleeve member 200, can stick into theinterior surface of the hole and thereby further establish purchase withthe bone and prevent inadvertent dislodging from the hole. In order toremove the sleeve member, the user need only rotate the sleeve member inthe opposite direction, which will release the edges or prongs fromengagement.

FIGS. 10A and 10B are side views of the sleeve member 200 and probe 300assembled with one another illustrating movement of the needle or probefrom a starting position (FIG. 10A) to an extended position (FIG. 10B)for measurement of a hole depth. FIGS. 11A and 11B are sidecross-sectional views of the sleeve member 200 and probe 300 assembledwith one another taken along lines C-C of FIGS. 10A and 10B,respectively. The surgical depth instrument further includes at leastone sensor configured to generate an electronic signal indicative of adepth of the hole as a result of sensing a distance of movement of theprobe 300 into the drilled hole. For example, as will be described ingreater detail herein, a surgeon need only advance the probe 300 intothe hole until they establish engagement between the distal tip 306 ofthe probe 300 with the anchored hook member 102. Again, the guidewire100 essentially acts as a guide upon which the probe 300 may eitherslide over, or slide alongside, when advancing to the anchored hookmember 102, which provides the datum from which the depth of the hole isdetermined.

The sensor is configured to generate an electronic signal based on adistance of movement of the probe 300, wherein the electronic signal isindicative of at least a depth of the hole. In particular, the sensormay include inductive or capacitive elements or assemblies configured tosense the location of the distal tip 306 of the probe 300 relative to adistal end 204 of the sleeve member 200, and, as a result, generate anelectronic signal representing the distance there between. Accordingly,the sensed distance between the distal end 204 of the sleeve member 200(when abutting the bone surface) and the distal tip of the probe member(when abutting the anchored hook member) is the depth of the hole.

FIGS. 12 and 13 are cross-sectional views of the sleeve member 200illustrating different sensor systems/arrangements for determining depthof a drilled hole based on movement of the probe 300. In someembodiments, the sensor system may include a potentiometer 210arrangement (FIG. 12). In some embodiments, as shown in FIG. 13, thesensor system for determining depth may include a worm gear measurementsystem, wherein the sleeve member 200 may include a pinion gear 212 andthe probe may have a corresponding worm gear configuration on itsexterior surface. Yet still, in some embodiments, the sensor system mayinclude a laser diode configured to read or otherwise sensemachine-readable markings on the probe to determine distance traveledwhen determining/calculating depth of the drilled hole.

It should be noted that the surgical instrument may include logic orallow for adjustment to the sensing capabilities so as to program thesensor to account for other variables when sensing the depth of thehole. For example, in some embodiments, certain procedures requirefixing a plate or implant to the bone via screws. Accordingly, the screwlength must not only be sufficient to fill the hole but also long enoughto account for the thickness of a plate or implant through which itpasses when engaging the hole. Accordingly, in some embodiments, thesensor may be programmed so as to account for the thickness of the plateor implant and will further include that thickness in the electronicsignal produced, such that the electronic signal is indicative of thetotal depth that a corresponding screw length will need to cover,including the depth of the hole in the bone in addition to the thicknessof the plate or implant through which the screw will pass through andthe screw head will engage.

Accordingly, the digital sensing of the hole depth provides a much moreaccurate measurement than conventional analog depth gauges and alsorequiring very little, if any, input or interpretation from the surgeon.Accordingly, by providing a much more accurate measurement of a holedepth, the surgeon is able to select the correct length screw for anygiven hole so as to improve the chances of a successful surgery.

In some embodiments, the surgical instrument may further include adisplay provided on the sleeve member 200, for example, and may beconfigured to visually provide a digital readout of a depth measurementof the hole based on the electronic signal from the sensor. In otherembodiments, the surgical depth instrument may be configured towirelessly communicate and exchange data with a separate display orcomputing device, such as, for example, a monitor or panel display, aPC, a notebook, a tablet computer, a smartphone, or other wirelesscomputing device.

Upon receiving the electronic signal from the sensor, the separatedisplay or computing device may be configured to visually provide thedepth measurement of the hole based on the electronic signal from thesensor. Furthermore, in some embodiments, the computing device mayinclude a specific software application that may be directed tomaintaining a record of the hole measurements and/or provide aninteractive user interface in which multiple holes can be mapped to aparticular plate or implant and the depth of each hole (including thethickness of the plate or implant) can be included and stored forrecords.

FIGS. 14A-14H illustrate a series of steps for performing a procedure ofdeploying the hook member 102 of the guidewire 100 and subsequentlyobtaining a depth measurement using the surgical depth instrument,specifically the sleeve member 200 and probe 300 consistent with thepresent disclosure. As shown in FIG. 14A, a procedure may begin in whichthe surgeon, or other medical professional, begins to advance theguidewire 100, specifically the hook member 102, into a drilled hole ina bone. The hook member 102 is in the delivery configuration, and due toits compact size while in the delivery configuration, the hook member102 may be freely positioned within and move through the drilled hole.In the figures, the hole is drilled entirely through the bone (i.e.,bicortical drill hole), and thus the surgeon advances the hook member102 entirely through the hole, as shown in FIG. 14B.

Upon reaching the desired position, the surgeon then actively controlstransitioning of the hook member from the delivery configuration to thedeployed configuration, as shown in FIG. 14C. In this instance, thesurgeon would like to obtain the depth of the hole for the purpose ofselecting the correct length of screw to use for the bicortical drillhole. Accordingly, upon transitioning the hook member to the deployedconfiguration, in which the expanded diameter is much greater than thedrilled hole diameter and opening, and the surgeon pulls back on theguidewire 100 until the expanded hook member 102 securely engages theexterior surface of the bone adjacent to the drilled hole, as shown inFIG. 14D. Due to the resilient nature of the material of the struts, thehook member 102 may essentially flatten against the surface of the bonein response to the surgeon pulling back on the guidewire 100, and theflattening may enhance tactile feel, providing the surgeon with anindication that the hook member 102 is sufficiently anchored.

At this point, with the guidewire secured 100 in position, the surgeoncan simply slide the sleeve member 200 over the guidewire 100 andfurther assembly the probe 300 with the sleeve member 200, as shown inFIG. 14E. In order to begin the depth measurement of the hole via theprobe 300, the surgeon may first advance the sleeve member 200, whilemounted to the guidewire 100, towards the opening of the hole until thedistal end 204 of the sleeve member 200 engages at least the opening ofa drilled hole, at which point, the flanged member 205 is configured toengage the exterior surface of the bone along a periphery of the holeopening, as shown in FIG. 14F. The distal end 204 of the sleeve member200 establishes engagement and maintains the sleeve member 200 in astabilized position, at which point, the probe 300 can be used formeasuring the depth of the hole. In particular, as shown in FIG. 14G,the surgeon advances the probe 300 within the hole until it reaches theanchored hook member 102, which serves as a stopping point for the probe300 and thus provides a datum from which the depth of the hole can bedetermined. Upon the distal tip 306 of the probe 300 engaging the hookmember 102, shown in FIG. 14H, the measurement of the depth of the holeis now complete, in that the sensor has determined the distance traveledby the probe 300 and thus is able to calculate the corresponding depthof the hole.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in oneembodiment” or “in an embodiment” in various places throughout thisspecification are not necessarily all referring to the same embodiment.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments.

The terms and expressions which have been employed herein are used asterms of description and not of limitation, and there is no intention,in the use of such terms and expressions, of excluding any equivalentsof the features shown and described (or portions thereof), and it isrecognized that various modifications are possible within the scope ofthe claims. Accordingly, the claims are intended to cover all suchequivalents.

1-19. (canceled)
 20. A method for the measurement of a hole formed in abone, the method comprising: introducing to a hole formed in a bone aguidewire comprising a deployable hook member configured to transitionbetween a delivery configuration, in which the hook member has a firstdiameter and is configured to be positioned within and move through thehole, and a deployed configuration, in which the hook member has asecond diameter greater than the first diameter; moving the hook memberthrough the hole; positioning the hook member within the hole;transitioning the hook member to the deployed configuration therebyanchoring the hook member at a position relative to the hole;introducing to the hole formed in the bone a surgical depth instrumentcomprising a sleeve member and a probe member cooperatively coupledthereto, the sleeve member having a distal end, a proximal end, and abore extending from the distal end to the proximal end, wherein the boreis configured to receive the guidewire therethrough, wherein the distalend of the sleeve member is configured to engage an opening of the holeupon movement of the sleeve member towards the hole, and wherein thedistal end of the sleeve member comprises one or more protrusionsconfigured to establish purchase with a portion of the interior surfaceof the hole upon rotation of the sleeve member, wherein the sleevemember and probe member are each configured to move relative to the hookmember along as axis of the guidewire, wherein the surgical depthinstrument is configured to obtain at least one measurement of the holebased, at least in part, on engagement between a distal tip of the probemember of the surgical depth instrument and the hook member when thehook member is in the deployed configuration; receiving the guidewire inthe bore of the sleeve member thereby slidably mounting the sleevemember to the guidewire; moving the sleeve member and the probe memberrelative to the hook member along an axis of the guidewire towards thehole; engaging an opening of the hole with the sleeve member; rotatingthe sleeve member thereby establishing purchase with a portion of theinterior surface of the hole; and obtaining at least one measurement ofthe hole based, at least in part, on engagement between the distal tipof the probe member and the hook member.
 21. The method of claim 20,wherein the probe member comprises an elongate body and the bore isconfigured to receive at least a portion of the elongate body of theprobe member and the distal tip of the probe member therethrough, andthe method comprises receiving at least a portion of the elongate bodyof the probe member and the distal tip of the probe member therethroughprior to moving the sleeve member and the probe member relative to thehook member along an axis of the guidewire towards the hole.
 22. Themethod of claim 21, wherein the distal tip of the probe member and aportion of the elongate body extends from the distal end of the sleevemember after being received by the bore.
 23. The method of claim 20,wherein the probe member comprises a hollow elongate body configured toreceive the guidewire therethrough to thereby slidably mount the probemember to the guidewire, and wherein the method comprises receiving theguidewire in the elongate body of the sleeve member thereby slidablymounting the sleeve member to the guidewire, prior to moving the sleevemember and the probe member relative to the hook member along an axis ofthe guidewire towards the hole;
 24. The method of claim 20, wherein thesurgical depth instrument further comprises a sensor configured togenerate an electronic signal indicative of a depth of at least thehole, wherein the electronic signal varies in relation to a distancetraveled by the probe member relative to the sleeve member, and whereinthe method comprises generating an electronic signal indicative of adepth of at least the hole.
 25. The method of claim 24, wherein thesensor is an electrical resistance-based sensor.
 26. The method of claim25, wherein the sensor comprises a potentiometer.
 27. The method ofclaim 24, wherein the sensor is configured to generate an electronicsignal based on a worm gear assembly.
 28. The method of claim 27,wherein the worm gear assembly comprises a pinion gear and the probemember comprises a corresponding worm gear arrangement on a surfacethereof.
 29. The method of claim 24, further comprising a display on thesleeve member configured to visually provide a digital readout of adepth measurement of the hole based on the electronic signal from thesensor, and wherein the method comprises visually providing a digitalreadout of a depth measurement of the hole based on the electronicsignal from the sensor.
 30. The method of claim 29, wherein the displayis a liquid crystal display or an LED display.
 31. The method of claim20, wherein after being transitioned into the deployed configuration,the hook member provides a datum from which the at least one measurementof the hole is based.
 32. The method of claim 20, wherein the hookmember comprises a plurality of struts, each having a distal end fixedto a common distal-most end of the guidewire and a proximal end fixed toa common portion of the guidewire positioned a distance from thedistal-most end of the guidewire.
 33. The method of claim 32, whereinthe guidewire further comprises a pull-wire coupled to the distal-mostend of the guidewire.
 34. The method of claim 33, wherein the hookmember is configured to transition from the delivery configuration tothe deployed configuration upon application of a pulling force to thepull-wire, and wherein transitioning the hook member to the deployedconfiguration comprises applying pulling force to the pull-wire.
 35. Themethod of claim 34, wherein the method comprises transitioning the hookmember to the delivery configuration and removing the guidewire from thehole after obtaining at the least one measurement of the hole.
 36. Themethod of claim 35, wherein the hook member is configured to transitionfrom the deployed configuration to the delivery configuration uponremoval of the pulling force from the pull-wire, and whereintransitioning the hook member to the delivery configuration comprisesremoval of the pulling force from the pull-wire.